MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number	DB-3216-55
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Pneumocephalus (4587)
Date of Event	06/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the stage two implant procedure of the deep brain stimulation (dbs) high impedances were observed on five contacts.Multiple attempts were made to resolve the impedances, such as disconnecting and reconnecting the lead extension from the lead however the impedances continued.Therefore, it was decided to switch out the lead extension with a new lead extension.However, the high impedances continue on one of the contacts, and it was determined that high impedances were on the left lead and not the lead extension.The physician assessed that the impedances may have been tissue related, that there may be an air bubble in the brain, however this was not confirmed.The procedure was prolonged and ultimately completed, the patient was admitted to the hospital overnight beyond standard of care and was discharged the following day and is doing well post operatively.It is unclear as to which of the two implanted leads, was placed on the left side and was exhibiting the high impedances.It is also unclear as to which of the two lead extensions was ultimately implanted and which was discarded by the facility during the procedure.
Additional Manufacturer Narrative
Block d2b pro code (product code): nhl additional suspect medical device component involved in the event: brand name: null, upn: m365db3216550, model: db-3216-55, serial: (b)(6), batch: 5007242, udi: (b)(4).Brand name: null, upn: m365db2203450, model: db-2203-45, serial: (b)(6), batch: 5009543, udi: (b)(4).Brand name: null, upn: m365db2203450, model: db-2203-45, serial: (b)(6), batch: 5009458, udi: (b)(4).

• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): Boston Scientific Corporation; road 698, lot no. 12; dorado PR 00646 -260; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25808847
• Report Number: 3006630150-2026-04907
• Device Sequence Number: 13423093
• Product Code: NHL
• UDI-Device Identifier: 08714729966395
• UDI-Public: (01)08714729966395(17)280303(10)5007241
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DB-3216-55
• Device Catalogue Number: DB-3216-55
• Device Lot Number: 5007241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Supplement Date Received by Manufacturer: Not provided; 09/28/2026
• Initial Report FDA Received Date: 07/14/2026
• Supplement Report FDA Received Date: 09/04/2026; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown